Medtronic Infuse Bone Graft Lawsuit Attorneys

Medtronic Infuse Bone Graft

FDA Grants Limited Approval for Medtronic Infuse Bone Graft

The Infuse Bone Graft was approved by the FDA on July 2, 2002. According to the manufacturer’s (Medtronic) website, the product is intended to be used to treat Lumbar Degenerative Disk Disease (DDD). It is also approved to treat a spinal condition called Degenerative Disc Disease; open fractures of the tibia; and two dental bone grafting procedures—sinus augmentation and localized alveolar ridge augmentation. The product is not approved for cervical procedures.

Purpose & Design

Traditionally lumbar degenerative disc disease is treated by performing a spinal fusion surgery. This surgery requires a portion of a hip bone to be harvested before it is used in the spinal fusion. It is intended to eliminate the need to use a portion of the hip bone by encouraging bone growth.

The Infuse Bone Graft consists of two parts: rhBMP-2, a protein that is found in everyone’s body, and a natural carrier for delivery. RhBMP-2 (recombinant (engineered) human bone morphogenetic protein-2) produces naturally in small amounts to regulate bone growth and healing. The second part of the it (the natural carrier) is a sponge manufactured from bovine (cow) Type 1 collagen. It releases the protein over time where it is placed, provides a scaffold (framework) for new bone to grow into, and is absorbed and eventually replaced by bone.

FDA Warns Against Infuse Bone Graft Procedure in Cervical Spine Procedures

In July of 2008, the FDA warned against use of Infuse Bone Graft for off label use in cervical spine procedures. The warning noted that patients who had undergone the procedure reported difficulty swallowing, speaking, and breathing. Several of these patients required emergency treatment—including tracheotomies and the insertion of feeding tubes— as well as second surgeries. Complications generally develop within two to fourteen days after the surgery.

Off Label Uses

The FDA prohibits medical device and pharmaceutical manufacturers from promoting their products for use in a manner that has not been approved by the FDA. In other words, a manufacturer can only promote a device for its FDA approved uses.

This restriction, however, does not apply to doctors, who are free to use medical devices and prescribe pharmaceuticals in any manner that they believe will benefit the patient. This practice, which is referred to as “off label” use,” is surprisingly quite common, and has lead to serious injuries and death.

In September of 2008, the Wall Street Journal reported that at least seventy-five percent of the 280 reported complications with the Medtronic Bone Graft involved off-label use. At least 38 of these reported complications were directly related to using the product for cervical spine applications. Most of these complications involved unwanted bone growth near nerves or in areas beyond the targeted fusion site. Medtronic attempted to discount the large number of complications caused by the Infuse Bone Graft by emphasizing that 680,000 units of Infuse Bone Grafts have been used in the United States to date.

Despite the large number of complications reported from cervical use of the Infuse Bone Graft, researchers from the Cleveland Clinic reported at the North American Spine Society that it was used “off label” in one out of every six surgeries.

Families Injured by the Medtronic Infuse Bone Graft Take Action

There have been at least three lawsuits filed again Medtronic arising from use of it in cervical spine (neck) procedures. The first lawsuit was filed by the family of a woman who received the Infuse Bond Graft in her neck and later died. The family alleges that the sales representative, who was present in the operating room when the procedure was performed, encouraged the off label use of the product.

In November 2008, U.S. Department of Justice issued a subpoena concerning the off label use of Medtronic Infuse Bone Grafts. Just one month later, a Medtronic Infuse wrongful death lawsuit was filed on behalf of a California woman who died after going into a coma caused by respiratory arrest following surgery. The Infuse bone replacement lawsuit alleged that Medtronic failed to warn about the risks associated with use of the device in the neck, and that Medtronic actively encouraged off-label uses, none of which have been approved by the FDA.

Three days after the California lawsuit was filed, Medtronic issued the following statement:

Medtronic’s technical consultant denies that he recommended the off-label use of the company’s product. FDA approved drugs and medial device products can be used by physicians in any way they deem proper, but companies are not allowed to promote off label applications or to induce physicians to do so.

The third lawsuit alleges that the graft used during the Plaintiff’s cervical spine fusion caused him to suffer severe swelling in the neck and throat, which impacted his ability to breath and required him to have an emergency tracheotomy. The lawsuit was filed against Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. in the U.S. District Court for the Southern District of New York.

Contact the Defective Medical Device Lawyers at Zehl & Associates Today: 1-888-603-3636

If you or a loved one experienced breathing or other health complications shortly after receiving a Medtronic Infuse Bone Graft in the cervical spine, you may have a claim against Medtronic for your personal injuries and economic damages. Call 1-888-603-3636 today for a free, no-commitment consultation.

The Medical Device Lawyers at Zehl & Associates have successfully resolved cases against major medical device and pharmaceutical companies located all over the world, and will devote whatever time and resources are necessary to obtain the maximum recovery for your injuries.

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I hired Zehl when I was severely injured doing a Plug and Abandonment job offshore. I'm glad I did, they were incredible. They walked me through every step of the case, made sure that I got to the best doctors, and were always there for me when I was having trouble paying bills when the case was pending. I always felt that I was in good hands and well taken care of, which relieved a lot of my stress and helped put me at ease. Eric and the team at Zehl and Associates represented my best interests, I highly recommend them.
Derrick Collins
Derrick Collins
21:03 14 Jun 17
I was hesitant to file a lawsuit when I was injured at work, because I didn't know what to expect and my company kept telling me that "they were going to take care of me." But the medical bills kept piling up, I wasn't able to work and make money to support my family. Eric Allen and the staff at Zehl put me at ease about the process, kept me to up date about what was going on, and devoted all their resources to making sure that I had the money I needed to pay all my medical expenses and take care of myself and my family. I can honestly say that working with Eric, Ryan and the Zehl team was one of the best decisions we've ever made. Thank you.
Maura Burnett
Maura Burnett
22:17 12 Jun 17
After I was injured at a chemical plant, I needed time to recover from my injuries and a lawyer who could stand up for me and my family against my company. Ryan Zehl was recommended to me from a coworker. Ryan worked hard to prepare my case and kept me and my family in the loop through the entire process. At the end they were able to get me a settlement that was much more than we had expected. I’d recommend Ryan and the team at Zehl to anyone who needs an injury lawyer who’s aggressive, honest and dedicated to protecting their clients.
Jeffrey Hutson
Jeffrey Hutson
15:47 12 May 17
Thanks to the hard work from Ryan and his team, a dangerous product that could have hurt thousands of people is now off the street. Even though I suffered from the lack of safety checks from this product, I am happy to have “taken the bullet”, to keep other people safe. Special thanks to Tommy Servos, who kept me informed through out the whole trial and helped me get a record recovery!
Kevin Nunn
Kevin Nunn
20:30 14 May 17
I grew up in Texas and went to work on an oil rig just like my dad did. It was a point of pride to follow in the same career path as my father, but no one warned me about the constant pending danger of being on the rig. My team and I are professionals that follow the rules and keep safety as priority number 1. But there are some factors to this job that can’t be controlled. Just like the BP Deep Water Horizon oil spill, my rig suffered an explosion due to the lack of up keep and maintenance from our superiors. Ryan Zehl came to our aid to get the compensation my crew and I needed. Having a Houston personal injury attorney from back home represent us was truly a personal and eye opening experience. He truly cared about us and thanks to him, I can recover with my family and the safety precautions on the rig have never been tighter.
Catherine J. Bates
Catherine J. Bates
02:23 06 Mar 17
Husband was killed at a refinery to the lack of safety checks performed by the company he worked for. When I found out he was gone I was so devastated and scared for our family I wasn’t sure what the next step would be. At first I thought his company would do the right thing and take care of us. But was I wrong. They tried to say we could only recover worker’s comp and had no claim against the company. I hired Ryan because of their experience with plant and refinery accident cases. I was so impressed at how professional and caring Ryan and his entire team were. They would call to check on me and my kids and always made sure I had money to pay bills and get presents for my kids on there birthdays and at Christmas. I don’t know where we’d be without there help. Because of Ryan and his team, I was able to pay off the house, put a trust together for my kids to make sure they’re able to pay for college, and never have to worry about having enough money to take care of myself and the kids again. We are so grateful for everything they did for us. Thank you.
Silvana Teixeira
Silvana Teixeira
06:52 06 Jun 17
Ryan and his team at Zehl & Associates were outstanding from when I first hired them to when they got my case settled. I couldn’t be happier with the results and the work at this law firm has done. I am very thankful and don’t hesitate to give them 5 out 5 stars! You want these guys are your side.
Jhon Abraham
Jhon Abraham
16:53 13 May 17
I came to Zehl Law Firm after I was injured in a car accident. They made me feel comfortable and explained things so I understood what to expect. Along with excellent communication. They were always quick to respond and update me on everything. Kelvin Hayes did a great job with my case and I would be happy to refer him to anyone looking for a auto injury lawyer.
Cody Pennington
Cody Pennington
21:31 03 Jul 17
I highly recommend Zehl Law! When I was injured on the job, I reached out to Ryan’s office and was greeted with support. I was well taken and care of and really appreciate how the law firm professionals went above and beyond their call of duty to help me. Now I can recover without having to worry about money until I am well enough to get back on the job. Thanks guys!
Anna Cris
Anna Cris
12:07 12 Jul 17
I can't even explain the blessing of having Zehl & Associates in our life. This firm has been like family to us and changed our lives forever. Great, friendly Law Firm that I recommend everyone to go to. One on one with your attorney, the fact that you dont have to worry about anything, they handle the whole process! I want to thank Zehl & Associates for an amazing job! #best personalinjurylawyers
Laura Blanco
Laura Blanco
04:00 17 Aug 17
Tommy Servos handled my dads pharmaceutical suit and thanks to all his hard work, my dad is now getting the proper treatment he needs and we won't have to worry about the hefty costs that come with it.
Pasquale D'argenzi
Pasquale D'argenzi
02:29 07 Jul 17
Thanks to Ryan and his team, I was able to get the compensation I deserved after being hurt while at work. They kept me up to date and made sure that I had everything I needed going forward. This group is top notch
Jason Cordell
Jason Cordell
03:02 05 May 17
We've had the opportunity to work jointly on cases with Ryan Zehl and his law firm. The attorneys at Zehl & Associates are smart, professional, and great to work with. I recommend them without hesitation.
Hughes Ellzey, LLP
Hughes Ellzey, LLP
18:28 13 Feb 18
From the first time I contacted Zehl and Associates I knew they were going to take care of me. No matter what came at us, they were on it. Ryan, Kevin, Matt and Jennifer they treat you like you are part of their family. They truly improve people's lives. When I retained Zehl and Associates Ryan and his team traveled to my home over 1500 miles from Houston, they sat in my living room and told me they would take care of me and my family. Ryan and his team took care of us! I would without a doubt recommend Zelh and Associates to anyone in need of a personal injury attorney! My only regret was not retaining them sooner. Let Ryan and Kevin get started on protecting you and your family today. Thanks Ryan and Kevin I will never forget you guys! #mywolfpack
Jeremy Hepner
Jeremy Hepner
04:27 13 Mar 18
i cant begin to tell you how pleased i am with zehl & associates. From Ms. Jennifer being very punctual with car pick up anywhere in Houston. Mrs. Sarah was very , very helpful with anything i needed explained when it came to the medical, she made it very understandable for someone who knows nothing about the medical field. i was also very pleased with Mr. Tommy in the financial side of everything i never had to wait for a phone call because he was always available. Mr. Eric handled my case very very well i couldn't believe how in depth and how aggressive he was with my case. Their was no stone left unturned he always kept me in the loop of things i always knew what was going on and i never had to worry. I honestly couldn't believe how everything was handled with my case. I never had anything to worry about they were very aggressive and handled everything very professionally i couldnt have been anymore pleased with Ryan and his team at zehl and associates. I highly, highly recommend to anybody that needs representation, to call Ryan and his team i promise you will not be disappointed
Lil Goldy
Lil Goldy
18:08 23 May 16
Ryan and his team are amazing. They understand the law, how to work up a case, and win at trial. Ryan gets great results quickly and knows how to maximize recovery for his clients. I unequivocally recommend Ryan to anyone who has been impacted by an injury or loss.
Kyle Watson
Kyle Watson
19:37 03 Apr 18
I was hit by an 18 wheeler on I-20 and injured more than I realized at the time. My truck flipped over and I ended up spending almost 3 weeks in the hospital after 4 surgeries. I'm so grateful that I found Zehl. They know what they're doing and they REALLY care. Whenever we needed something, they were there for us the entire time...from getting me to the best doctors to helping us out at Christmas so we could get presents for the kids. Ryan recommended that we turn down the truck company settlement and get the case ready for trial. I'm glad I listened, because the truck company ended up paying 4 times more than the settlement we turned down. Ryan and his team are the best!
Marcie Lyndell
Marcie Lyndell
03:15 06 Apr 18
Ryan and his firm are sharp lawyers and tough advocates for their clients. I highly recommend them.
Rusty Sewell
Rusty Sewell
14:07 06 Apr 18
Just wanted to say how grateful I am to all of the lawyers at Zehl & Associates for the tremendous effort that was put into my case and the large settlement that I received from it. I have never met a more knowledgeable and respectful group of people. I was in a refinery explosion with third degree burns all over my body. Needless to say it was an absolute terrifying time in my life, but I felt great comfort after talking to the Z&A team. They immediately knew what to do, and secured a large settlement for me that not only gets me the best medical care for life, but also pays for both of my boys to go to any college they want. It also allows me and my wife to live the rest of our lives without ever having to worry about how we're going to pay the bills. Thank you again for the all the hard work.
Warren Bane
Warren Bane
16:18 06 Apr 18
I was injured in an offshore platform explosion in the Gulf of Mexico where over 150 people, including myself, were injured and 2 people were killed. The companies responsible for causing the explosion hired a team of lawyers that fought me and my co-workers every step of the way. We were getting pushed around by the companies and their lawyers, until we hired Zehl & Associates. Zehl & Associates took our case, and got it ready for trial. When it came time to go to trial, the companies offered an amount as settlement that went way beyond my expectations. An offer that would not have been possible without Zehl & Associates hard work and diligence. Beyond the settlement, which helped me and family out tremendously as I could no longer work, Zehl & Associates treated me like family. Ryan and his team were always available to make sure that me and my family had everything we needed while the case was pending. I would recommend Zehl & Associates to anyone who was injured and needed the best personal injury lawyers to fight for them.
Sam Lepow
Sam Lepow
21:42 06 Apr 18
My husband was injured. This was such a scary time for myself and my family. My husband retained Zehl and Associates and immediately came a sense of relief as they paid medical bills that caused us a great deal of stress. They really took care of my husband....even came to our home over 1000 miles away. Ryan and his team were amazing! They truly took care of him and treated him like family. Thank you Zehl & Associates for all that you did for our family!
Jill Hepner
Jill Hepner
04:24 10 Apr 18
I was injured at work and did not know what firm to use. I found Zehl & Associates online and I am glad that I did. From the very beginning they explained the process and exactly what would happen step by step. Eric, Vickye and the rest of the Zehl staff were amazing to me. I am confident that I made the right choice in choosing Zehl & Associates to represent me. Every time I had a question they would respond back to me immediately. I definitely got more than I could ask for and knew that I was in good hands.
Tim Holbrook
Tim Holbrook
14:36 10 Apr 18
I was injured in 2016 while working offshore. I did not know what to do. I found Zehl & Associates online and called them immediately. From the first time I spoke with Eric he made me feel confident that I would have a positive outcome. I have worked all my life and not being able to work left me feeling scared an anxious. Eric always did a great job of explaining each step of the case to me, he explained it to me in terms that I could understand. Everyone that I meet at Zehl & Associates were kind and professional. Eric did a great job resolving my case.
Steven Randolph
Steven Randolph
14:41 10 Apr 18
On may way to work one morning, I was rear ended at high speed by an 18 wheeler. I suffered head, neck,and back injuries due to the truck driver's negligence. As a husband and father to 3 young children, I did not know what to do. I was suffering from some very serious symptoms as a result of the collision. I must admit that I was apprehensive about contacting an attorney at this point. But, did so as the severity of my injuries became more evident. I contacted Zehl & Associates to seek the help that my family so desperately needed. From the first phone conversation with the staff, I knew that I had made the right decision. The law office took immediate action for me. They assisted me in getting the highest quality medical treatment by some of the most respected physicians in the medical field. My family and I were treated with the most sincere respect possible. The staff at the office was top notch and very responsive to every request.They began to prepare my case for trial from day one. I quickly realized that the competence level of the attorneys and staff was absolutely through the roof. Proof of this was the fact that I agreed to a settlement that amounted in over 4 times what the defendant offered at mediation. It far exceeded my expectations. My family and I now have the financial security and satisfaction to know that we will be taken care of for the rest of my life. I will forever owe a huge debt of gratitude to the entire team at Zehl & Associates. I would not hesitate at all to recommend them to anyone who has been injured and is in need of help. Total dedication, respect and competence is what you can expect. We are one thankful family!!!!Tommy East
red bonnet
red bonnet
17:11 10 Apr 18
Zehl & Associates are a rare and truly unique group of personal injury attorneys. Beyond their impressive undefeated record each member of their team from the receptionists to Ryan Zehl himself take care of their clients as if they were members of their own families. To be a fly on the wall in their office is to witness the overwhelming amount of joy and expertise that Zehl & Associates pours into every case they are entrusted with. While justice for personal injury may often times be bittersweet Zehl & Associates have managed to prove to myself and others that for them justice it's worth fighting for no matter who walks through their door. I can't express enough how much that type is ethic is worth when you're in midst of an ongoing tragedy and need someone to fight for you and your family. I would highly recommend Zehl & Associates to anyone involved in a personal injury accident. My parting advice would be to call them sooner than later. Don't let your current situation no matter how dire consume you. With Zehl and Associates representing your case you have a team of legal experts and genuinely good hearted people going to bat for you.
Jeremy Jones
Jeremy Jones
17:23 12 Apr 18
When you need help, choosing an attorney is the most important decision you will have to make. My husband was seriously injured, when the tug boat he was working on, sank in the Gulf of Mexico. With the help of Kevin, Eric and their wonderful team, we were taken care of every step of the way. Vickye made sure that all of our questions and concerns were addressed and answered in a timely manner. They went above and beyond our expectations. We were treated with understanding and respect and made sure that all of our needs were met. We highly recommend Zehl and Associates.
Dinah Pitre
Dinah Pitre
00:23 21 Apr 18
I have never been in a situation to where I needed the help from a firm. I would like take the time to identify not just one person but the entire staff representing Zehl & Associates. They were punctual and focused diligently on providing me the help I needed after experiencing a truck accident. They made themselves available to me and reassured me that this is how a client should be treated with respect and when I had questions they had answers for me. Please... if you having a hard time deciding on a firm take heed to my review and give Zehl & Associates the opportunity to earn your business. You won’t be disappointed.
Peter Apuyan
Peter Apuyan
21:03 26 Apr 18
I would like to start out by saying that an accident that involves injuries are never easy to adapt to. Zehl and Associates made my ordeal a lot smoother than i expected. All my appointments and prescriptions were taken care of. My medication was delivered at my front door. If I needed transportation they supplied it for me. Zehl and Associates are hands down the best personal injury lawyers. During my ordeal i had no problems getting in contact with my lawyer. As we know communication is the biggest problem with law firms. After you obtain a lawyer it is hard to speak with him afterward. These guys treat you like family not a client. I can honestly say that they had my best interest in mind. As far as getting results in a case I can't express my satisfaction. These guys far exceeded my expectation.. i CAN'T BE HAPPIER! if you want results these are the guys. I could go on about these guys but words won't do justice. THANKS ZEHL AND ASSOCIATES!
Patrick Bridges
Patrick Bridges
21:38 25 May 18
Theres not enough stars to rate the true quality on here! Everything I've heard about lawyers went out the window when Eric took time on Father's day of all days to contact me back and help assist me with a settlement. I was in desperate need of legal advice & guidance and running out of time. Eric was quick, efficient, HONEST, and did more than beyond more to make sure I was legally protected & being treated fairly. I was at my giving up point on everything until that first conversation with Eric. Zehl Law definitely breaks the mold on lawyers. He was more interested in protecting me than trying to take money from me. Which is a rare thing to find in any industry or just people in general, which has definitely been my case involving everything else in my life. But of all people, a lawyer restored my faith in humanity itself. Thank you for that. Thank you for everything! You've been more than amazing!!!
Arielle Fletcher
Arielle Fletcher
18:41 22 Jun 18
Eric was able to help our company by providing truthful and helpful legal counsel. We are extremely happy with how quickly he was able to resolve the issue and get back to us. Very professional and genuinely caring people.
Stan Ivanov
Stan Ivanov
14:17 20 Jul 18
I can not describe how blown away I am by this law firm. From the first phone call I was directed to Eric Allen, who was so helpful in my situation. I had a complicated legal matter that he was so knowledgeable on and he was able to provide honest and supportive feedback. I am so glad that Google search led me to these people. Please look no further if you are looking for an attorney that will take care of you. Eric, thank you again for your help!!
Marina Ivanov
Marina Ivanov
14:15 20 Jul 18
Honest review I don’t normally do this but I do not like false 5 star reviews. I left Mr. Zehl 2 emails the office never called me back. I received automatic replies stating someone would contact me but that never happened. Do not believe the reviews contact a different attorney and do not waste your time. If this is how they treat potential new clients imagine how they will represent you in court.
Frank Guerra
Frank Guerra
12:48 01 Aug 18
Ryan Zehl is the best, very nice, helpful, and compassionate. His firm works very hard to help you! I hired them because my brother was killed on a work site, the firm's track record, and they seemed to really care about their clients and cases. Thank you all at Zehl & Associates for your help.
Rhonda M
Rhonda M
20:33 02 Oct 18
I wanted to express my outmost gratitude and appreciation to the Zehl&Associates law firm for the excellent representation in my accident case in December 2016; even though it was a difficult case I could not have been more pleased with how they handled everything. They are very knowledgeable and clearly the top in their field. I would highly recommend them. Thanks Zehl&Associates.
Arturo Estrada
Arturo Estrada
17:19 11 Dec 18